NCT04934007

Brief Summary

According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Sep 2021Sep 2027

First Submitted

Initial submission to the registry

June 7, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 6, 2021

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

June 7, 2021

Last Update Submit

January 12, 2026

Conditions

Obsessive-Compulsive Disorder

Keywords

rTMSD-B80 A/P

Outcome Measures

Primary Outcomes (1)

  • Yale Brown Obsessive Compulsive Scale score

    Significant clinical change (≥ 25%) from baseline to two weeks after the treatment sequence, assessed by a significant reduction in YBOCS scores at day 25

    baseline and 25 days

Secondary Outcomes (6)

  • Yale Brown Obsessive Compulsive Scale

    baseline and 70 days

  • general assessement functioning (GAF)

    baseline and 25 days

  • general assessement functioning (GAF)

    baseline and 70 days

  • Clinical Global Impression (CGI)

    baseline and 25 days

  • Clinical Global Impression (CGI)

    baseline and 70 days

  • +1 more secondary outcomes

Study Arms (2)

Active stimulation

EXPERIMENTAL

Active rTMS stimulation , 2 session per day during 10 days.

Device: rTMS Treatment

Sham Stimulation

SHAM COMPARATOR

Sham rTMS stimulation , 2 session per day during 10 days.

Device: rTMS Treatment

Interventions

rTMS TreatmentDEVICE

1 Hz rTMS

Active stimulationSham Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: Participants will be both males and females, 18-65 years of age included.
  • diagnosis of OCD
  • all the patients must have failed to respond to at least two different pharmacological treatment used for at least 6 weeks
  • Affiliation to a social security system (recipient or assignee),
  • Signed written inform consent form

You may not qualify if:

  • In accordance with the safety criteria for rTMS, patients with a history of seizure or bearing pacemakers, mobile metal implants, implanted medical pumps, or metal clips placed inside the skull will also be excluded
  • The patients won't be allowed to change their medication during the trial. The treatment must be stable at least 3 week before day 0.
  • Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
  • Patient under curators
  • Patient hospitalized under duress
  • Patient unable to give his or hers informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sorbonne University, Pitié-Salpêtrière Hospital

Paris, France

RECRUITING

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Ghina Harika-Germaneau

    Centre Hospitalier Henri Laborit

    STUDY DIRECTOR

Central Study Contacts

Ghina Harika-Germaneau, MD, PhD

CONTACT

+33 5 16 52 61 18ghina.harika.germaneau@ch-poitiers.fr

Nematollah Jaafari, PR

CONTACT

+33 5 16 52 61 18nemat.jaafari@ch-poitiers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 22, 2021

Study Start

September 6, 2021

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

FR(2)